01 1GLAND PHARMA LIMITED
01 1ISAVUCONAZONIUM SULFATE
01 1India
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2025-08-25
Pay. Date : 2025-07-22
DMF Number : 41887
Submission : 2025-06-13
Status : Active
Type : II
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Gland Pharma Ltd, based in India, is a pharmaceutical company that stands out with its certifications from FDA, EDQM and WHO-GMP.
One of their notable products is ISAVUCONAZONIUM SULFATE, with a corresponding US DMF Number 41887.
Remarkably, this DMF maintains an Active status since its submission on June 13, 2025, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of August 25, 2025, and payment made on July 22, 2025, indicating their dedication to facilitating drug approvals, Categorized as Type II
